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If a more rapid transition from agonist to antagonist therapy is deemed necessary and appropriate by the healthcare providermonitor the patient closely in an appropriate medical setting where precipitated withdrawal can be managed.

Cases of hepatitis and clinically significant liver dysfunction were observed in association with REVIA exposure during the clinical development program and in the postmarketing periodTransientasymptomatic hepatic transaminase elevations were also observed in the clinical trials and postmarketing periodWhen patients presented with elevated transaminasesthere were often other potential causative or contributory etiologies identifiedincluding pre-existing alcoholic liver diseasehepatitis B and/or C infectionand concomitant usage of other potentially hepatotoxic drugsAlthough clinically significant liver dysfunction is not typically recognized as a manifestation of opioid withdrawalopioid withdrawal that is precipitated abruptly may lead to systemic sequelaeincluding acute liver injury.

Patients with addictive disordersespecially opioid addictionare at risk for multiple numerous adverse events and abnormal laboratory findingsincluding liver function abnormalitiesData from both controlled and observational studies suggest that these abnormalitiesother than the dose-related hepatotoxicity described aboveare not related to the use of REVIA.

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